Stent-valve and deployment catheter for use therewith

Abstract

A stent-valve device includes a non-collapsible valve component and a stent component having a first ring connected to a second ring. The first ring has a characteristic first diameter and a valve support for supporting the valve component. The second ring is contractible and expandable between a second diameter less than a third diameter. The second diameter is less than the first diameter and the third diameter is greater than the first diameter. The first ring preferably includes a plurality of elements that extend downward to feet that project radially inward. The valve component rests on the feet for support. A seal is preferably disposed about the first ring. The valve component may be mechanical valve prosthesis, a bio-prosthesis (such as a non-collapsible porcine valve) or a polymer-based prosthesis. In another aspect of the invention, a deployment catheter is provided for effectively deploying the stent-valve device(s) described herein.

1 . A stent-valve device comprising: 
 a non-collapsible valve component; and    a stent component having a first ring connected to a second ring, said first ring having a characteristic first diameter and a valve support which supports said valve component, and said second ring being contractible and expandable between a second diameter less than a third diameter, wherein said second diameter is less than said first diameter and said third diameter is greater than said first diameter.    
   
   
       2 . A stent-valve device according to  claim 1 , wherein: 
 said valve support comprises a plurality of elements that extend downward to feet that project radially inward.    
   
   
       3 . A stent-valve device according to  claim 1 , further comprising: 
 a seal disposed about said first ring.    
   
   
       4 . A stent-valve device according to  claim 1 , further comprising: 
 a plurality of suspension elements that connect said first ring to said second ring.    
   
   
       5 . A stent-valve device according to  claim 1 , wherein: 
 said second ring comprises a band of hexagonal elements having upper apices and lower apices extend radially outward in a manner that fixates said stent-valve device in place against an inner wall of a blood vessel.    
   
   
       6 . A stent-valve device according to  claim 1 , wherein: 
 said second ring includes means for fixing said second ring in place against an inner wall of a blood vessel; and    said stent-valve device further comprises a plurality of suspension elements that connect said second ring to said first ring.    
   
   
       7 . A stent-valve device according to  claim 1 , wherein: 
 said stent component is realized from at least one shape memory metal.    
   
   
       8 . A stent-valve device according to  claim 1 , wherein: 
 said valve component comprises a substantially rigid annular base and a plurality of flexible leaflets that extend from said base.    
   
   
       9 . A stent-valve device according to  claim 8 , wherein: 
 said valve component is one of mechanical valve prosthesis, a bio-prosthesis, and a polymer-based prosthesis.    
   
   
       10 . A stent-valve device according to  claim 9 , wherein: 
 said valve component comprises a non-collapsible porcine valve.    
   
   
       11 . An apparatus comprising: 
 a stent-valve device including 
 a valve component, and  
 a stent component having a first ring connected to a second ring, said first ring having a characteristic first diameter and a valve support which supports said valve component, and said second ring being contractible and expandable between a contracted state and an expanded state, said contracted state having a second diameter less than a third diameter of said expanded state, wherein said second diameter is less than said first diameter and said third diameter is greater than said first diameter; and  
   a deployment catheter including 
 a first housing that is adapted to store said second ring in its contracted state, and  
 means for moving said first housing axially to deploy said second ring from said first housing whereby it expands to its expanded state.  
   
   
   
       12 . An apparatus according to  claim 11 , wherein: 
 said deployment catheter includes a first body member, operably coupled to said first housing, that is manipulated to effectuate axial movement of said first housing, and a restrictor member, operably disposed adjacent said second ring, that is adapted to limit axial movement of said second ring while said first body member is moved axially to deploy said second ring.    
   
   
       13 . An apparatus according to  claim 12 , wherein: 
 said deployment catheter further comprises a second body member, operably coupled to said restrictor that is manipulated to effectuate axial movement of said first body member relative to said restrictor member.    
   
   
       14 . An apparatus according to  claim 13 , wherein: 
 said second body member is concentric over said first body member.    
   
   
       15 . An apparatus according to  claim 13 , wherein: 
 said valve component comprises an annular base and a plurality of flexible leaflets that extend from said base, and    said deployment catheter includes a second housing that is adapted to extend through said valve component.    
   
   
       16 . An apparatus according to  claim 11 , wherein: 
 said valve component is non-collapsible.    
   
   
       17 . An apparatus according to  claim 16 , wherein: 
 said valve component comprises a substantially rigid base and a plurality of leaflets that extend from said base.    
   
   
       18 . An apparatus according to  claim 16 , wherein: 
 said valve component is one of mechanical valve prosthesis, a bio-prosthesis, and a polymer-based prosthesis.    
   
   
       19 . An apparatus according to  claim 15 , wherein: 
 said deployment catheter further comprises a third body member adapted to effectuate axial movement of said second housing relative to said restrictor member and said first housing.    
   
   
       20 . An apparatus according to  claim 19 , wherein: 
 said second body member is concentric over said first body member, and said third body member is concentric over both said first and second body members.    
   
   
       21 . An apparatus according to  claim 11 , wherein: 
 said valve support comprises a plurality of elements that extend downward to feet that project radially inward.    
   
   
       22 . An apparatus according to  claim 11 , wherein: 
 said stent-valve further comprises a seal disposed about said first ring.    
   
   
       23 . An apparatus according to  claim 11 , wherein: 
 said stent component further comprises a plurality of suspension elements that connect said first ring to said second ring.    
   
   
       24 . An apparatus according to  claim 11 , wherein: 
 said second ring comprises a band of hexagonal elements having upper apices and lower apices that extend radially outward in a manner that fixates said stent-valve device in place against an inner wall of a blood vessel.    
   
   
       25 . An apparatus according to  claim 11 , wherein: 
 said second ring includes means for fixing said second ring in place against an inner wall of a blood vessel; and    said stent-valve further comprises a plurality of suspension elements that connect said second ring to said first ring.    
   
   
       26 . A surgical method comprising: 
 providing an apparatus comprising a stent-valve device loaded into a deployment catheter, 
 said stent-valve device including a valve component and a stent component having a first ring connected to a second ring, said first ring having a characteristic first diameter and a valve support for supporting said valve component, and said second ring being contractible and expandable between a contracted state and an expanded state, said contracted state having a second diameter less than a third diameter of said expanded state, wherein said second diameter is less than said first diameter and said third diameter is greater than said first diameter, and  
 said deployment catheter including a first housing that stores said second ring in its contracted state, and means for effectuating axial movement of said first housing relative to said second ring;  
   inserting said apparatus into the body and guiding said deployment catheter to an intended deployment site;    axially moving said first housing relative to said second ring to cause said second ring to deploy from said first housing and automatically expand from its contracted state to its expanded state, whereby in its expanded state said second ring fixates said stent-valve device to an inner wall of a blood vessel at or near the intended deployment site; and    retracting said deployment catheter to remove it from the human body.    
   
   
       27 . A surgical method according to  claim 26 , wherein: 
 said first housing is moved axially forward to cause said second ring to deploy from said first housing.    
   
   
       28 . A surgical method according to  claim 26 , wherein: 
 said deployment catheter includes 
 a first body member adapted to effectuate axial movement of said first housing,  
 a restrictor member, operably disposed adjacent said second ring, that is adapted to limit axial movement of said second ring, and  
 a second body member adapted to effectuate axial movement of said restrictor member; and  
   wherein the method further comprises the step of manipulating said second body member to limit axial movement of said restrictor member while moving said first body member axially to deploy said second ring from said first housing.    
   
   
       29 . A surgical method according to  claim 28 , wherein: 
 said valve component is non-collapsible, and    said deployment catheter includes 
 a second housing that extends through said valve component, and  
 a third body member adapted to effectuate axial movement of said second housing, and  
   wherein the method further comprises the step manipulating said third body member to retract said second housing from said valve component.    
   
   
       30 . A surgical method according to  claim 26 , wherein: 
 said valve component is non-collapsible and preferably comprises a substantially rigid annular base and a plurality of flexible leaflets that extend from said base.    
   
   
       31 . A surgical method according to  claim 30 , wherein: 
 said valve component is one of mechanical valve prosthesis, a bio-prosthesis, and a polymer-based prosthesis.    
   
   
       32 . A surgical method according to  claim 30 , wherein: 
 said valve component comprises a non-collapsible porcine valve.    
   
   
       33 . A surgical method according to  claim 26 , wherein: 
 said valve support comprises a plurality of elements that extend downward to feet that project radially inward.    
   
   
       34 . A surgical method according to  claim 26 , wherein: 
 said stent-valve further comprises a seal disposed about said first ring.    
   
   
       35 . A surgical method according to  claim 26 , wherein: 
 said stent component further comprises a plurality of suspension elements that connect said first ring to said second ring.    
   
   
       36 . A surgical method according to  claim 26 , wherein: 
 said second ring comprises a band of hexagonal elements having upper apices and lower apices that extend radially outward in a manner that fixates said stent-valve device in place against an inner wall of a blood vessel.    
   
   
       37 . A surgical method according to  claim 26 , wherein: 
 said second ring includes means for fixing said second ring in place against an inner wall of a blood vessel; and    said stent component further comprises a plurality of suspension elements that connect said second ring to said first ring.    
   
   
       38 . A surgical method according to  claim 26 , wherein: 
 the intended deployment site is within the ascending aorta of the heart with said first ring positioned adjacent the left ventricle of the heart and said second ring positioned above the coronary arteries.    
   
   
       39 . A surgical method according to  claim 26 , wherein: 
 the deployment catheter is introduced below the intended deployment site.    
   
   
       40 . A surgical method according to  claim 26 , wherein: 
 the deployment catheter is introduced above the intended deployment site.